[Data infrastructures for health research : Ethical framework and legal implementation]

Area of Science:

• Health Research Data Infrastructures
• Data Governance and Ethics
• Personal Data Protection

Context:

• Data infrastructures extend beyond mere data exchange services.
• They actively participate in and bear responsibility for data sharing processes.
• This includes ensuring lawfulness of personal data processing.

Purpose:

• To define the responsibilities of data infrastructures in health research.
• To outline legal and ethical obligations concerning data processing and subject rights.
• To emphasize the importance of public welfare, participation, transparency, and scientific communication.

Summary:

• Data infrastructures must ensure data processing aligns with consent or statutory bases.
• They are responsible for implementing data subject rights (information, rectification, erasure).
• Infrastructures must also manage incidental or additional findings.
• Ethical considerations include public welfare, participation, transparency, and scientific communication.

Impact:

• Adherence to ethical and legal standards is crucial for establishing stakeholder trust.
• Trust is the foundation for the successful development and operation of health data infrastructures.
• This promotes secure and responsible data sharing in health research.